Reinforced mesh for retropubic implants

ABSTRACT

Disclosed are reinforced meshes for retropubic implants for treatment of urinary incontinence and/or pelvic floor disorders and related uses, devices, and methods. In certain embodiments, implants have various resilient strengthening members added to a retropubic support mesh.

RELATED APPLICATIONS

This application claims the benefit of U.S. Provisional Application Ser.No. 60/878,311, filed Jan. 2, 2007 and titled “Reinforced Mesh forRetropubic Implants,” the entire contents of which are incorporatedherein by reference.

BACKGROUND

Pelvic floor disorders are a class of abnormalities that affect thepelvic region of patients, and they afflict millions of women. Thepelvic region includes various anatomical structures such as the uterus,the rectum, the bladder, and the vagina. These anatomical structures aresupported and held in place by a complex collection of tissues, such asmuscles and ligaments. When these tissues are damaged, stretched, orotherwise weakened, the anatomical structures of the pelvic region shiftand in some cases protrude into other anatomical structures. Forexample, when the tissues between the bladder and the vagina weaken, thebladder may shift and protrude into the vagina, causing a pelvic floordisorder known as cystocele. Other pelvic floor disorders includevaginal prolapse, vaginal hernia, rectocele, enterocele, uterocele,and/or urethrocele.

Pelvic floor disorders often cause or exacerbate female urinaryincontinence (UI). One type of UI, called stress urinary incontinence(SUI), effects primarily women and is often caused by twoconditions-intrinsic sphincter deficiency (ISD) and hypermobility. Theseconditions may occur independently or in combination. In ISD, theurinary sphincter valve, located within the urethra, fails to close (or“coapt”) properly, causing urine to leak out of the urethra duringstressful activity. In hypermobility, the pelvic floor is distended,weakened, or damaged. When the afflicted woman sneezes, coughs, orotherwise strains the pelvic region, the bladderneck and proximalurethra rotate and descend. As a result, the urethra does not close withsufficient response time, and urine leaks through the urethra. Often,treatments of stress incontinence are made without treating the pelvicfloor disorders at all, potentially leading to an early recurrence ofthe stress incontinence.

UI and pelvic floor disorders, which are usually accompanied bysignificant pain and discomfort, are often treated by implanting asupportive sling in or near the pelvic floor region to support thefallen or shifted anatomical structures or more generally, to strengthenthe pelvic region by promoting tissue ingrowth. Such slings may be madefrom a variety of materials, but are often made from a mesh material. Amesh may be placed, for example, under the urethra, close to thehigh-pressure zone with little or no elevation to the urethra. Whenabdominal pressure increases, such as from coughing, sneezing, or thelike, the sling facilitates the collapse of the urethra as a mechanismfor closing the urethra to inhibit urine leakage. As another example, awider mesh may be placed under the bladder to prevent it from protrudinginto other anatomical structures such as the vagina.

Various methods exist for implanting and securing slings. Some methodsuse soft tissue anchors to secure the slings to specific locationswithin the patient. These methods require highly accurate sling lengthto insure the sling aligns with the appropriate anchoring locationswhile creating the correct balance of tension and slack under theurethra or prolapsed organ. Some securement methods rely on theintrinsic coarseness of the edges of the mesh material to adhere to thepatient's tissue, requiring the sling to have a substantial length.However, many current procedures, such as transobturator (TOT) andsingle incision procedures, require a shorter sling.

After the sling is implanted, the mesh material of the sling stretchesand becomes less resilient, losing its ability to collapse the urethraor support the prolapsed organ. Scar tissue may form around the sling,further securing the sling within the patient and facilitating urethralclosure or prolapsed organ support, but the scar tissue formation may beimpeded by the stretching of the mesh. Previous methods forstrengthening the sling typically reduced or did not address the sling'sability to be secured within the patient.

There is need for a sling with prolonged mesh material resilience,improved stimulation of scar tissue ingrowth, and a stronger securementmethod that is less dependent on sling length.

SUMMARY

The invention relates generally to systems and methods for improving theretention, resilience, and strength of surgically implantable supportiveimplants for use in treating urinary incontinence and/or pelvic floorconditions in a patient. More specifically, in various embodiments, theinvention is directed to mesh implants featuring various resilientstrengthening members added to a retropubic support mesh. These membersmay adhere to the patient's suburethral or pelvic floor tissues,reinforce the mesh material, stimulate scar tissue ingrowth, or somecombination thereof. Moreover, these members may obviate the need for ananchor and allow for the use of a relatively short mesh length. In onerespect, the invention includes an implant adapted to support apatient's pelvic or retropubic tissues. The implant includes a meshhaving at least one longitudinal edge and at least one longitudinalsurface and being sized and shaped to support one or more of a patient'surethra, bladderneck, and pelvic organ; and a resilient strengtheningmember disposed within or on the mesh and protruding beyond one or moreof a longitudinal edge and a longitudinal surface.

In certain embodiments, the resilient strengthening member protrudesbeyond a first longitudinal edge of the mesh and a second longitudinaledge of the mesh. The resilient strengthening member can also attach tothe mesh at a plurality of points. In certain embodiments, the resilientstrengthening member is a rigid member having a portion adapted topenetrate a tissue of a patient. In certain embodiments, the resilientstrengthening member is fibrous and/or is one or more of compositeplastic or metal. The rigid member can be shaped as desired, and may becurved, spherical, bulky, oblong, or otherwise shaped. The rigid membercan be disposed obliquely with respect to the longitudinal edge,substantially perpendicular to the longitudinal edge, or substantiallyparallel to the longitudinal edge. The resilient strengthening membercan include a rigid member deposited on a surface of the mesh.

In certain embodiments, the mesh is configured in an irregular shape forpelvic organ support, and can include one or more securement straps,where at least one of the one or more securement straps includes aresilient strengthening member disposed in an end region of thesecurement strap. An end region of the mesh may be configured in anirregular shape for securing to a location within the patient. Incertain embodiments, the resilient strengthening member is disposed inan end region of the mesh. The resilient strengthening member may bedisposed inward from an end edge of the mesh and/or at least about 25%of a way from an end of the mesh to a center of the mesh. The resilientstrengthening member may also be spaced away from a center region of themesh, where the center region is adapted to be adjacent to one or moreof the patient's urethra, bladderneck, and pelvic organ.

In certain embodiments, the implant includes an anchor disposed at anend of the mesh for securing the implant to soft tissue within apatient. The mesh can include one or more regions having tangs thatproject from a longitudinal edge.

In certain embodiments, the implant includes a plurality of resilientstrengthening members. The implant may further include a first pluralityof resilient strengthening members disposed in a first end region of themesh and a second plurality of resilient strengthening members disposedin a second end region of the mesh. In certain implementations, two ormore resilient strengthening members directly connect and may be affixedto each other. In certain embodiments, at least one resilientstrengthening member couples to a plurality of other resilientstrengthening members.

In another aspect, the invention includes methods for implanting asurgical implant in the retropubic space or other region of a patient'spelvic floor. In one exemplary method, the operation creates an incisionin the vaginal wall of the patient; couples an implant to a deliverydevice, wherein the implant is a mesh implant having a longitudinaledge, a longitudinal surface, and a resilient strengthening memberdisposed within or on the mesh implant and protruding beyond one or moreof the longitudinal edge and the longitudinal surface; and inserts thedelivery device through the vaginal incision via the external vaginalopening of the patient to extend a portion of the implant within thepatient's pelvic region. In certain embodiments, the method alsoincludes guiding the device to a location beneath the patient'sepidermis to secure the implant in the patient's soft tissue.Transobtural, transabdominal, prepubic, suprapubic, and other methodsmay be used.

BRIEF DESCRIPTION OF THE FIGURES

Features and advantages of the invention will be more fully understoodby the following illustrative description with reference to the appendeddrawings in which like elements are labeled with like referencedesignations and which may not be drawn to scale.

FIGS. 1A and 1B depict, respectively, a top view and a side view of asling mesh.

FIGS. 2, 3, 4A, and 4B depict various exemplary meshes incorporatingstiffening members with the sling of FIGS. 1A and 1B.

FIGS. 5 and 6 depict various exemplary meshes incorporating stiffeningmembers with the sling of FIGS. 1A and 1B.

FIGS. 7 and 8 depict various exemplary meshes incorporating stiffeningmembers with the sling of FIGS. 1A and 1B.

FIGS. 9A and 9B depict, respectively, a top view and a side view of anexemplary mesh incorporating stiffening members that protrude fromsurfaces of the sling of FIGS. 1A and 1B.

FIGS. 10A and 10B depict an exemplary mesh incorporating strengtheningknots protruding from surfaces of the sling of FIGS. 1A and 1B.

FIG. 11 depicts an exemplary mesh incorporating strengthening fiberswith the sling of FIGS. 1A and 1B.

FIG. 12 depicts an exemplary mesh incorporating strengthening knots andfibers with the sling of FIGS. 1A and 1B.

FIGS. 13, 14A, and 14B depict various exemplary mesh shapesincorporating resilient strengthening members.

FIGS. 15A and 15B depict, respectively, a top view and a side view of anexemplary mesh incorporating a plurality of resilient strengtheningmembers disposed on and within the sling of FIGS. 1A and 1B.

FIGS. 16A-16E depict exemplary soft tissue anchors that may be used withthe implants disclosed herein.

FIGS. 17A-17C depict exemplary soft tissue anchors and techniques forimplantation in a patient's tissue.

FIGS. 18 and 19 depict various exemplary pelvic floor meshesincorporating strengthening members.

FIG. 20 depicts an exemplary tanged mesh incorporating strengtheningmembers.

FIG. 21 depicts an exemplary sleeve for use in delivering an exemplarymesh.

FIG. 22 depicts an exemplary delivery device that can be used to deliveran exemplary mesh to an anatomical location in the body of a patient.

FIG. 23 illustrates an exemplary vaginal incision procedure that usesthe delivery device of FIG. 22 to deliver an exemplary mesh.

FIGS. 24A-24C depict an exemplary delivery device that can be used todeliver an exemplary mesh.

FIG. 25 illustrates an exemplary transobturator approach for deliveringan exemplary mesh to an anatomical location in the body of a patient.

FIGS. 26A and 26B illustrate an exemplary transobturator approach usingthe delivery device of FIGS. 24A-24C to delivery exemplary meshes.

DETAILED DESCRIPTION OF CERTAIN EXEMPLARY EMBODIMENTS

The invention relates generally to systems and methods for improving theretention, resilience, and strength of surgically implantable supportiveimplants for use in treating urinary incontinence and/or pelvic floorconditions in a patient. More specifically, in various embodiments, theinvention is directed to mesh implants featuring various resilientstrengthening members added to a retropubic support mesh. These membersmay adhere to the patient's suburethral or pelvic floor tissues,reinforce the mesh material, stimulate scar tissue ingrowth, or somecombination thereof. Moreover, these members may obviate the need for ananchor and allow for the use of a relatively short mesh length.

FIGS. 1A and 1B depict, respectively, a top view and a side view of amesh 100 used in supportive slings for urethral support. The mesh shapehas a center region 102, which may be configured to support the urethraand/or a prolapsed organ, surrounded by two opposing end regions 104 aand 104 b that are adapted to be implanted in a patient's tissue to holdthe mesh in the pelvic region of the patient. The mesh 100 also has twolongitudinal top and bottom surfaces 106 a and 106 b that are bounded bylongitudinal edges 108 a and 108 b. The longitudinal edges 108 a and 108b may have tangs, which in certain embodiments are ends of fibers of themesh material, that project from the nominal longitudinal edges 108 aand 108 b of the mesh 100. The tangs may hook into and adhere to thepatient's tissue or stimulate scar tissue ingrowth. The mesh materialfeatures a network of regularly spaced holes 105 that serve as a latticeupon which scar tissue may grow. Perpendicular to the length of the mesh100 is a width 110. Both the width 110 and a length of the mesh 100 maybe selected based on the specific anatomical structures being supportedand the procedure for implanting the mesh 100. For example, the depictedmesh 100 can have a longitudinal length of between about 6 cm and about15 cm to extend laterally between both of the patient's obturatorforamen, and an anterior-to-posterior width 110 of between about 0.5 cmand about 2 cm to support the urethra and/or bladderneck. Longer orshorter lengths may be appropriate, depending on the procedure forimplanting the mesh 100. Wide meshes may also be used in systems thatsupport the bladder, uterus, rectum or other pelvic organ, as discussedbelow. Note that the fibers or other members that make up the mesh 100may be obliquely oriented with respect to the length and width 110 ofthe mesh 100.

FIGS. 2-9B depict certain exemplary meshes incorporating variousstiffening members in different orientations. As described, thestiffening members are disposed with respect to (and in certainembodiments secured to) the mesh material to help strengthen the mesh100 depicted in FIG. 1 and may protrude in various orientations andarrangements to help hold the mesh 100 in place and stimulate scartissue ingrowth. Suitable materials and methods for manufacturingstiffening members and attaching them to the mesh 100 are describedbelow. Generally, a stiffening member is less elastic and less flexiblethan the mesh 100 (e.g., the strands or other members that are used tomake the mesh), and may impart a relative rigidity to the part of themesh 100 to which it is attached (e.g., because the stiffening member isattached to the mesh at several points along the length of thestiffening member). The stiffening members thereby help preventsignificant stretching of the mesh 100.

FIGS. 2-4B depict exemplary meshes that incorporate straight stiffeningmembers 128, 146, and 166 that lie in the plane of the mesh 100 depictedin FIG. 1, protrude from the longitudinal edges 108 a and 108 b, and aredisposed in the end regions 104 a and 104 b of the mesh 100. Eachstraight stiffening member has longitudinal edge protrusions adapted topenetrate the patient's tissue to help secure the end regions 104 a and104 b to the body and stimulate scar tissue ingrowth at the end regions104 a and 104 b.

FIG. 2 depicts an exemplary mesh 120 incorporating straight stiffeningmembers 128 that are transverse to the longitudinal axis of the mesh 120and arrayed at varying distances from one another. The straightstiffening members 128 each have longitudinal edge protrusions 130 a and130 b adapted to penetrate the flesh to help secure end regions 122 aand 122 b of the mesh 120 to the body and stimulate scar tissue ingrowthat the end regions 122 a and 122 b. The straight stiffening members 128are disposed in the end regions 122 a and 122 b, perpendicular tolongitudinal edges 124 a and 124 b of the mesh 120 to help reduce themesh's ability to stretch. In particular, for a diagonal mesh similar tomesh 100 depicted in FIG. 1, the width 110 of the mesh 100 typicallynarrows to allow the mesh 100 to lengthen. The straight stiffeningmembers 128 help maintain a width 126 of the mesh 120 (e.g., becauseeach stiffening member is secured to the mesh at several points alongthe length of the stiffening member), which may prevent significantstretching of the mesh 120.

FIG. 3 depicts an exemplary mesh 140 incorporating straight stiffeningmembers 146 arrayed in non-overlapping X shaped structures 150 uniformlyspaced in each end region 142 a and 142 b of the mesh 140. Each Xstructure 150 has a “left” straight stiffening member 146 a and a“right” straight stiffening member 146 b which cross (and may optionallybe secured together) at a crossing point 152 that lies substantiallynear the center of each straight stiffening member 146 a and 146 b. Inother words, both stiffening members 146 a and 146 b in an X structure150 are generally transverse to the longitudinal axis of the mesh 140,but neither is truly perpendicular to the axis. In addition, eachstiffening member in the X structure 150 forms a different angle withthe longitudinal axis. By orienting the straight stiffening members 146along at least two different directions transverse to the longitudinalaxis of the mesh 140, one direction generally parallel to the leftstraight stiffening member 146 a and another direction generallyparallel to the right straight stiffening member 146 b, the mesh 140 mayprevent significant stretching of the mesh 140 along either direction aswell as along other directions. This feature is enhanced by securingeach stiffening member 146 to the mesh 140 at several points along thelength of the stiffening member 146. The straight stiffening members 146are also oriented obliquely with respect to longitudinal edges 144 a and144 b, allowing the longitudinal edge protrusions 148 a and 148 b toextend from the longitudinal edges 144 a and 144 b at acute angles whichhook the end regions 142 a and 142 b into the flesh.

FIG. 4A depicts an exemplary mesh 160 incorporating straight stiffeningmembers 166 arrayed in overlapping X structures 170 and disposed at eachend region 162 a and 162 b of the mesh 160. Similar to each X structure150 of FIG. 3, each X structure 170 has a “left” straight stiffeningmember 166 a and a “right” straight stiffening member 166 b which cross(and may optionally be secured together) at a crossing point 172 thatlies substantially near the center of each straight stiffening member166 a and 166 b. In contrast to FIG. 3, each X structure 170 of mesh 160is configured to overlap with at least one other X structure 170 toincrease the points on the mesh 160 that have contact (and are thusstabilized by) the straight stiffening members 166. Increasing themesh's contact with straight stiffening members 166 may impart morestrength and resilience to the mesh material.

FIG. 4B depicts an exemplary mesh 180 incorporating straight stiffeningmembers 186 disposed at each end region 182 a and 182 b of the mesh 180and arrayed in overlapping X structures 190 similarly to members 166 ofFIG. 4A. Similar to each X structure 170 of FIG. 4A, each X structure190 has a “left” straight stiffening member 186 a and a “right” straightstiffening member 186 b which cross (and may optionally be securedtogether) at a crossing point 192 that lies substantially near thecenter of each straight stiffening member 186 a and 186 b. In contrastto FIG. 4A, the overlapping X structures 190 are configured to berelatively close and can form multiple regions 194 a, 194 b, 196 a, and196 b of overlap within each end region 182 a and 182 b. In addition tofurther increasing the number of points on the mesh 180 that havecontact with straight stiffening members 186, the configuration of mesh180 can advantageously create a plurality of (and optimally, more thantwo) securement locations along the length of the mesh 180.

FIGS. 5 and 6 depict exemplary meshes incorporating bent stiffeningmembers 208 and 228, respectively, that lie in the plane of the mesh 100depicted in FIG. 1, protrude from the longitudinal edges 108 a and 108b, and are disposed uniformly within the end regions 104 a and 104 b ofthe mesh 100. Each stiffening member 208 and 228 is secured to the meshmaterial at several points along the length of the stiffening member tohelp impede stretching of the mesh 100.

More particularly, FIG. 5 depicts an exemplary mesh 200 incorporatingbent stiffening members 208 that are disposed generally transverse andoblique to the longitudinal axis of the mesh 200. Each stiffening member208 has a long portion 210 with a portion 212 protruding from alongitudinal edge 204 b of the mesh 200, and a short portion 214 joinedto the long portion 210 to form a joint (or bend) 216, with the shortportion 214 protruding from an opposing longitudinal edge 204 a of themesh 200. The bend 216 forms an angle ⊖ between portions 210 and 214,which is about 100° in FIG. 5. In certain embodiments the angle of thebend 216 is greater than 90°, while in certain embodiments the angle ⊖is between about 90° and about 150°. In other embodiments the angle ⊖ isless than about 90°. In certain embodiments the angle is about 45° orless.

As shown, the bend 216 allows the edge protrusions 212 and 214 to extendfrom longitudinal edges 204 a and 204 b of the mesh 200 at acute anglesto anchor end regions 202 a and 202 b of the mesh 200 into the tissue.In particular, the bent stiffening members 208 are oriented such thatthe longitudinal edge protrusions 212 and 214 are angled towards acenter region 206, forming hooks along longitudinal edges 204 a and 204b that are oriented to provide retrograde force in opposition to forcesthat arise during use and pull the end regions 202 a and 202 b towardsthe center region 206. The stiffening members 208 may also be disposedat varying distances along the mesh 100 depicted in FIG. 1 inconfigurations in which they overlap or form any other suitablearrangements and orientations.

FIG. 6 depicts an exemplary mesh 220 incorporating stiffening members228 that have long portions 230 disposed generally transverse to thelongitudinal axis of the mesh 220. Each stiffening member 228 also haslongitudinal edge protrusions 232 a and 232 b joined to the longportions 230 to form bends 234 a and 234 b. The bends 234 a and 234 bform angles ⊖ and ⊖′, respectively, between the long portion 230 andrespective edge protrusions 232 a and 232 b. The protrusions 232 a and232 b are adapted to penetrate the patient's tissue. In particular, andsimilar to the structure depicted in FIG. 5, the bends 234 a and 234 ballow the longitudinal edge protrusions 232 a and 232 b to extend fromlongitudinal edges 224 a and 224 b of the mesh 220 at acute angles whichhook end regions 222 a and 222 b of the mesh 220 into the tissue. Inparticular, the bent stiffening members 228 are oriented such that thelongitudinal edge protrusions 232 a and 232 b are angled towards acenter region 226, forming hooks along longitudinal edges 224 a and 224b that are oriented to provide retrograde force in opposition to forcesthat arise during use and pull the end regions 222 a and 222 b towardsthe center region 226. Similar to the straight stiffening members 128 ofthe mesh 120 depicted in FIG. 2, long portions 230 of the stiffeningmembers 228 are substantially perpendicular to the longitudinal edges224 a and 224 b of the mesh 220 to help prevent significant longitudinalstretching of the mesh 220. The stiffening members 228 may also bedisposed at varying distances along the mesh 100 depicted in FIG. 1, inconfigurations in which they overlap or form any other suitablearrangements and orientations.

FIGS. 7 and 8 depict exemplary meshes incorporating curved stiffeningmembers 246 and 268 disposed in the mesh 100 depicted in FIG. 1. Asshown, the members 246 and 268 protrude from the longitudinal edges 108a and 108 b and are disposed in the end regions 104 a and 104 b of themesh 100. Each stiffening member 246 and 268 is secured to the meshmaterial at several points along the length of the stiffening member tohelp prevent significant stretching of the mesh 100. In certainimplementations the members are disposed within the mesh by weavingthrough the holes 105. The members may also be glued, riveted,heat-melted or otherwise attached.

FIG. 7 depicts an exemplary mesh 240 incorporating curved stiffeningmembers 246 arrayed in overlapping X structures 250. Similar to the Xstructures 170 depicted in FIG. 4, each X structure 250 has a “left”curved stiffening member 246 a and a “right” curved stiffening member246 b which cross (and may optionally be secured together) at a crossingpoint 252 that lies substantially near the center of each curvedstiffening member 246 a and 246 b. In other words, both stiffeningmembers 246 a and 246 b in an X structure 250 are disposed generallytransverse and oblique to the longitudinal axis of the mesh 240. Inaddition, each stiffening member in the X structure 250 forms adifferent angle with the longitudinal axis. By orienting each pair ofcurved stiffening members 246 in at least two directions, one directiongenerally parallel to the left curved stiffening member 246 a andanother direction generally parallel to the right curved stiffeningmember 246 b, the mesh 240 is enhanced to impede stretching and thusrender the mesh 240 more suitable for providing retropubic support insome patients. This feature may be enhanced by securing each curvedstiffening member 246 to the mesh material at one or more points alongthe length of the mesh 240.

As shown, the curved stiffening member 246 has a slight curvature 254and protrusions 248 a and 248 b adapted to penetrate the patient'stissue. The curvature 254 allows the protrusions 248 a and 248 b toextend from longitudinal edges 244 a and 244 b of the mesh 240 at acuteangles not necessarily coplanar with the mesh 240. Because theorientation of the curvature 254 of each curved stiffening member 246may vary within the mesh 240, the angles at which the protrusions 248 aand 248 b extend from the mesh 240 also vary, allowing end regions 242 aand 242 b of the mesh 240 to anchor to a non-uniformly shaped surface ofthe patient's tissue.

FIG. 8 depicts an exemplary mesh 260 incorporating curved stiffeningmembers 268 arrayed approximately parallel to one another and transverseto the longitudinal axis of the mesh 260. Similarly to the straightstiffening members 128 of the mesh 120 depicted in FIG. 2, the curvedstiffening members 268 are substantially perpendicular to thelongitudinal axis of the mesh 260 to help prevent significant stretchingof the mesh 260. Similarly to the curved stiffening member 246 in FIG.7, the curved stiffening member 268 has a slight curvature 272 andprotrusions 270 a and 270 b adapted to penetrate the patient's tissue.The curvature 272 allows the protrusions 270 a and 270 b to extend fromlongitudinal edges 264 a and 264 b of the mesh 260 at acute angles notnecessarily coplanar with the mesh 260. Because the orientation of thecurvature 272 of each curved stiffening member 268 may vary within themesh 260, the angle at which the protrusions 270 a and 270 b extend fromthe mesh 260 may also vary, allowing end regions 262 a and 262 b of themesh 260 to anchor to a non-uniformly shaped surface of the patient'stissue. The curved stiffening members 268 may also be disposed in themesh 260 such that the curvature 272 of each curved stiffening member268 is oriented as desired. For example, the curved stiffening members268 could be oriented such that the protrusions 270 a and 270 b curvetoward a center region 266 of the mesh 260, forming hooks alonglongitudinal edges 264 a and 264 b that are oriented to provide aretrograde force in opposition to forces that arise during use and pullthe end regions 262 a and 262 b towards the center region 266. This mayhelp provide a more secure fit for some patients.

FIGS. 9A and 9B depict, respectively, a top view and a side view of anexemplary mesh 280 incorporating curved stiffening members 286 that liesubstantially in the plane of the mesh 280. As shown, members 286protrude somewhat from top and bottom surfaces 284 a and 284 b of themesh 280 and are disposed in end regions 282 a and 282 b thereof. Eachstiffening member 286 may be secured to the mesh 280 at one or morepoints along the length of the stiffening member 286. The orientation ofthe curvature 290 of each curved stiffening member 286 alternates alongthe length of the mesh 280 (i.e., some members 286 are concave up andsome are concave down), providing a substantially uniform arrangement ofprotrusions 288 a and 288 b from both the top and bottom surfaces 284 aand 284 b for securing the end regions 282 a and 282 b to the patient'stissue. The curved stiffening members 286 are aligned parallel tolongitudinal edges 292 a and 292 b of the mesh 280, which helps preventsignificant longitudinal stretching of the mesh 280. In certainimplementations, the longitudinal stretching can be further impeded byattaching one or more of stiffening members 286 to the mesh 280 atseveral points along the length of the stiffening member 286, as notedearlier. While protrusions 288 a and 288 b may be maintained along thetop and bottom surfaces 284 a and 284 b, the curved stiffening members286 may also be disposed at varying distances along the mesh 280, inconfigurations in which they overlap, and in any other suitablearrangements and orientations.

FIGS. 10A-14B depict embodiments of exemplary meshes incorporatingvarious fibrous members. The fibrous members may include strengtheningknots and/or fibers in various thicknesses and combinations. Asdescribed in the illustrative exemplary embodiments, the strengtheningknots and fibers may lie adjacent or interlaced with the holes 105 ofthe mesh 100 depicted in FIG. 1 to reinforce the mesh material. Theknots and fibers may also be disposed uniformly or non-uniformly in theend regions 104 a and 104 b and, optionally, protrude from the top andbottom surfaces 106 a and 106 b to help improve mesh resilience, holdthe mesh in place, and/or stimulate scar tissue ingrowth. Suitablematerials and methods for manufacturing fibrous members and attachingthem to the mesh 100 are described below.

FIGS. 10A and 10B depict top and side views of an exemplary mesh 300incorporating strengthening knots 306 that are disposed non-uniformlythroughout end regions 302 a and 302 b of the mesh 300, creating anirregular surface along both top and/or bottom surfaces 304 a and 304 bof the mesh 300. For example, a knot may be formed by tying a fiberaround strands of the mesh 300 between two adjacent holes in the mesh300. Knots 306 may also be formed by hot polymer that is dripped orotherwise applied to the mesh and then allowed to cool. Thestrengthening knots 306 may encourage scar tissue ingrowth and reinforcethe material of the mesh 300. The strengthening knots may vary in size,with larger knots protruding more and potentially providing morestrength than small knots, but also requiring more material to produce.

FIG. 11 depicts an exemplary mesh 320 incorporating strengthening fibers328 disposed in various orientations and non-uniformly throughout endregions 322 a and 322 b of the mesh 320. Each of the depictedstrengthening fibers 328 are interlaced within the holes 326 of the mesh320 and secured to the mesh 320 at several points along the length ofthe fibers, which helps reinforce the resiliency of the mesh materialand counteract stretching by the material. Portions of eachstrengthening fiber 328 may be configured to protrude from top and/orbottom surfaces 324 a and 324 b (not shown) to create an uneven surfacealong those surfaces, which may encourage scar tissue ingrowth.Strengthening fibers 328 may vary in thickness and length, with thickerstrengthening fibers generally protruding more and longer strengtheningfibers generally providing more resilience.

FIG. 12 depicts an exemplary mesh 340 incorporating a combination ofstrengthening knots 344 and fibers 346 disposed in end regions 342 a and342 b of the mesh 340. In certain embodiments, the strengthening knots344 and fibers 346 are manufactured from the same material (e.g.,polypropylene). In other implementations, the knots are formed ofdifferent material than the fibers.

The configuration of the strengthening components may be selected toachieve a desired mesh fit. For example, the strengthening knots 344 maybe configured to protrude from a surface of the mesh 340 more than thestrengthening fibers 346, which may allow the knots 344 to interact withthe patient's tissue for anchoring to the tissue and/or stimulating scartissue ingrowth. In other embodiments, the strengthening fibers 346 areconfigured to attach to more mesh surface area than do the strengtheningknots 344, which may better strengthen the mesh material and resiststretching in some patients.

FIGS. 13, 14A, and 14B depict exemplary meshes 360, 380, and 400,respectively, featuring various mesh shapes and incorporating exemplaryresilient strengthening members. The various mesh shapes, relative tothe mesh 100 depicted in FIG. 1, have extended surface areas at endregions 104 a and 104 b, increasing the amount of surface area availablefor scar tissue in-growth and enhancing the ability of the end regions104 a and 104 b to secure to the patient's tissues.

FIG. 13 depicts an exemplary mesh 360 with extended portions 372 a and372 c of the mesh material at end region 362 a and extended portions 372b and 372 d of the mesh material at end region 362 b. The extendedportions 372 a, 372 b, 372 c, and 372 d are each configured as atrapezoidal tab, with portions 372 a and 372 b disposed lateral to alongitudinal edge 364 a and portions 372 c and 372 d disposed lateral toa longitudinal edge 364 b. The extended portions 372 a, 372 b, 372 c,and 372 d can fold inwardly to maintain a width 370 of the mesh 360 toreduce the delivery profile of the implant. A delivery profile refers tothe maximum cross-sectional area of a passageway through the patient'sanatomy that is required for delivery of the implant. The deliveryprofile may be affected by one or more of a number of factors, includingthe diameter of the delivery needles, shafts, and/or dilators, implantwidth, and protective sleeve width. Reducing the delivery profile of theimplant decreases the size of an incision through which the mesh 360must travel during implantation. In certain embodiments, the deliveryprofile of the mesh is low, but the mesh is configured to expand (e.g.,by the unfolding of one or more extended portions 372 a-372 d) uponimplantation to provide added anchoring security. In certainembodiments, the extended portions 372 a, 372 b, 372 c, and 372 d may bedisposed closer to or further from a center region 366 of the mesh 360,as desired for implantation in particular locations. To help improvemesh resiliency and strength, the mesh 360 may include one or moreresilient strengthening members, such as strengthening knots 374, whichare shown disposed in end regions 362 a and 362 b. The mesh 360 may alsohave one or more of any of the other strengthening members disclosedherein.

FIG. 14A depicts an exemplary mesh 380 with extended portions 392 a and392 c of the mesh material at end region 382 a and extended portions 392b and 392 d of the mesh material at end region 382 b. The extendedportions 392 a, 392 b, 392 c, and 392 d each include a plurality oftabs, with portions 392 a and 392 b disposed lateral to the longitudinaledge 384 a and portions 392 c and 392 d disposed lateral to longitudinaledge 384 b. The extended portions 392 a, 392 b, 392 c, and 392 d canfold inwardly to maintain a width 390 of the mesh 380 to decrease thedelivery profile of the mesh 380. The mesh 380 may have one or moretangs disposed along the longitudinal edges 384 a and 384 b to helpstimulate scar tissue ingrowth and tissue adherence by the end regions382 a and 382 b. In certain embodiments, the tangs anchor the mesh insoft tissue. The extended portions 392 a, 392 b, 392 c, and 392 d may bedisposed closer or further from a center region 386 of the mesh 380 asdesired for implantation in desired locations. To help improve meshresiliency and strength, the mesh 380 may have various resilientstrengthening members, such as strengthening fibers 394, which are showndisposed in end regions 382 a and 382 b. The mesh 380 may also have oneor more of any of the other strengthening members disclosed herein.

FIG. 14B depicts an exemplary mesh 400 with extended portions 412 a and412 c of the mesh material at end region 402 a and extended portions 412b and 412 d of the mesh material at end region 402 b, similar toextended portions 392 a-392 d of FIG. 14A. The extended portions 412 a,412 b, 412 c, and 412 d each include a plurality of rounded tabs, withportions 412 a and 412 b disposed lateral to longitudinal edge 404 a andportions 412 c and 412 d disposed lateral to longitudinal edge 404 b.The extended portions 412 a, 412 b, 412 c, and 412 d can fold inwardlyto maintain a width 410 of the mesh 400 to decrease the delivery profileof the mesh 400. The mesh 400 may have one or more tangs disposed alongthe longitudinal edges 404 a and 404 b to help stimulate scar tissueingrowth and tissue adherence by the end regions 402 a and 402 b. Incertain embodiments, the tangs anchor the mesh in soft tissue. Theextended portions 412 a, 412 b, 412 c, and 412 d may be disposed closeror further from a center region 406 of the mesh 400 as desired forimplantation in desired locations. To help improve mesh resiliency andstrength, the mesh 400 may have various resilient strengthening members,such as strengthening knots 414 and fibers 416, which are shown disposedin end regions 402 a and 402 b. The mesh 400 may also have one or moreof any of the other strengthening members disclosed herein.

FIGS. 15A and 15B depict, respectively, a top view and a side view, ofan exemplary aggressive mesh 420 incorporating a plurality of resilientstrengthening members disposed on and within the mesh 420 and adapted toimprove mesh resiliency and ability of the mesh 420 to adhere to thepatient's tissue. As shown, the resilient strengthening members includeretention nodules 428, strengthening bars 430, soft tissue anchors 432,and other members such as those described herein. Suitable materials andmethods for manufacturing resilient strengthening members and attachingthem to the mesh 100 are described below.

One or more of the retention nodules 428 has a conical point thatprotrudes from the top and bottom surfaces 424 a and 424 b of the noduleor nodules. The nodules 428 may be deposited on one or more exteriorsurfaces without necessarily penetrating through them, and each mayattach at several points at which strands of the mesh 420 intersect orcross. The nodules 428 thus may strengthen the mesh material and createan irregular surface of pointed bumps conducive to scar tissue ingrowth.In one embodiment, the nodules 428 may be disposed on only one of thetop and bottom surfaces 424 a and 424 b, for example only on the topsurface 424 a as shown. This embodiment may be advantageous for caseswhen there are regions of the mesh 420 where it is desirable that onesurface interacts with the patient's tissue but the opposing surfacedoes not.

The depicted strengthening bars 430 are rigid, have an oblong shape, andlie within the plane of the mesh 420 preferably parallel to longitudinaledges 426 a and 426 b. The bars 430 may be deposited on and penetratethrough top and bottom surfaces 424 a and 424 b, and preferably eachattach at several points to strands of the mesh. The bars 430 helpimprove the resiliency and stability of the mesh material bycounteracting any tendency to stretch. The bars 430 may also be orientedgenerally transverse to the longitudinal axis of the mesh or accordingto any other suitable orientations and arrangements. The bars may beformed of plastic, metal, composites, or any other suitable stiffeningmaterial.

Anchors 432 are disposed coplanar to the mesh 420 at end regions 422 aand 422 b. The mesh 420 also has an optional anchor 432 disposed on oneor more ends. The anchors 432 serve to anchor end regions 422 a and 422b of the mesh 420 to anchoring locations within the patient's body.Various anchor implementations are described in U.S. patent applicationSer. No. 11/152,898, entitled “Systems, Methods and Devices Relating toImplantable Supportive Slings,” and/or in U.S. application Ser. No.11/400,111, entitled “Systems, Devices and Methods for Treating PelvicFloor Disorders,” filed Apr. 6, 2006, the contents of which are herebyincorporated by reference in their entirety, each of which is hereinincorporated by reference in its entirety.

Other exemplary soft tissue anchors that may be used with the meshesdescribed herein are depicted in FIGS. 16A-17A. In FIG. 16A, the anchor440 includes a through-aperture 442, a body 444 and two rows of radialprojections, or barbs 446. The through-aperture 442 couples to a shaftof a delivery device by fitting around the shaft, as will be discussedbelow. The depicted through-aperture 442 extends axially entirelythrough the body 444 of the anchor 440. In other embodiments, the body444 includes a passage extending axially from the proximal end 440 b ofthe anchor 440 only part way to the distal end 440 a of the anchor 440.

The barbs 446 are relatively short (e.g., less than about 2 millimetersin length) and relatively wide (e.g., between about 1 millimeter andabout 2 millimeters in width/diameter). Additionally, they haverelatively flat terminal ends 448. The barbs 446 are also flexible. Whenan operator inserts the anchor 440 into an obturator membrane, the barbs446 flex and compress against the body 444 of the anchor 440 to allowpassage at least partially through the obturator membrane. Afterinsertion within the obturator membrane, the barbs 446 expand radiallyfrom the body 444 and thereby resist retrograde motion back through theobturator membrane, thereby impeding the anchor 440 from disengagingfrom the obturator membrane.

FIG. 16B shows an alternative embodiment of an anchor 450, having athrough-aperture 452, a body 454 and two rows of radial projections 456.The projections 456 are relatively long (e.g., greater than or equal toabout 2 millimeters in length) and relatively wide (e.g., between about1 millimeter and about 2 millimeters in width/diameter), as comparedwith anchor 440 of FIG. 16A.

FIG. 16C shows another embodiment of an anchor 460 having a body 462, anaxially extending through-aperture 464 and radial projections 466. Theanchor 460 is similar to anchors 440 and 450 of FIGS. 16A and 16B,respectively, except that the radial projections 466 have pointed ratherthan flat terminal ends, in contrast to the projections 446 and 456. Thepointed projections 466 impede retrograde forces that may be applied tothe anchor 460, since the projections 466 more firmly incise into andengage with the tissue of the obturator membrane and thereby preventdisengagement of the anchor 460 from the obturator membrane. Inparticular, the projections have an initial width at a base 468comparable to the width of the projections 446 and 456, and have alength similar to that of the projections 446.

FIG. 16D shows another illustrative anchor 480, including a relativelylong (e.g., between about 2.5 centimeters and about 3.5 centimeters)body 482 and five rows of relatively long (e.g., greater than about 5millimeters) radial projections 484. As in the case of the abovedescribed examples, the anchor 480 includes a radially extendingthrough-passage 486.

FIG. 16E shows the barbed anchor 480 coupled to a portion of a surgicalimplant 490 and anchored to an obturator membrane 492. In operation, anoperator drives the anchor 480 partially (as illustrated) or entirelythrough the obturator membrane 492 using a delivery device and/or methodthat will be discussed below. The barbs 484 on the anchor 480 engagewith the obturator membrane 492 and inhibit the anchor 480 fromretracting out of the membrane 492 after insertion. An operator thenoptionally drives the anchor 480 further into the obturator membrane 492to tension the associated surgical implant 490. The long body 482 isbeneficial in part because the operator can drive the anchor 480 variousdistances through the obturator membrane 492, corresponding to varioustensions of implant 490. When the operator drives the anchor 480entirely through the obturator membrane 492, the surgical implant 490 isdriven through the obturator membrane 492. The implant 490 may havetangs and/or resilient strengthening members to engage with and anchorto the obturator membrane 492. The operator can then extend or retract aportion of the implant 490 through the obturator membrane 492 to tensionthe implant 490.

FIGS. 17A-17C depict an exemplary barbless soft tissue anchor and acorresponding technique for using the anchor. FIG. 17A illustrates asoft tissue anchor 500 having a smooth outer surface 502. Like theanchors depicted in FIGS. 16A-16E, the anchor 500 includes athrough-aperture 504 that fits around the shaft of a delivery device, aswill be discussed below. The depicted through-aperture 504 extendsaxially entirely through the anchor 500. In other embodiments, theanchor 500 includes a passage extending axially from the proximal end500 b of the anchor 500 only part way to the distal end 500 a of theanchor 500.

FIGS. 17B and 17C illustrate an exemplary technique for using the anchor500 to anchor a surgical implant 506 to an obturator membrane 508. Inparticular, an operator forms an aperture 510 within the obturatormembrane 508 using, for example, a needle or dilator. Next, the operatorcouples the anchor 500 to an implant 506 using methods discussed below.The operator then drives the anchor 500 through the aperture 510. Whenretrograde tension is applied to the implant 506, the anchor 500 pivotsto a horizontal orientation, depicted in FIG. 17C, and aligns with theobturator membrane 508, and this horizontal orientation prevents theanchor 500 from disengaging from the obturator membrane 508.

FIGS. 18 and 19 depict exemplary meshes 520 and 540, respectively, sizedand shaped for prolapsed organ support. Relative to the mesh 100depicted in FIG. 1, the pelvic floor meshes 520 and 540 are wider andmay have more end regions for securing the mesh within the patient. Themesh material of pelvic floor meshes 520 and 540 have a network ofspaced holes 1605 and 1705, respectively, that serve as a lattice uponwhich scar tissue may grow. The mesh shape and arrangement of endregions may be selected as desired, depending on the shape and locationof the prolapsed organ. The pelvic floor meshes 520 and 540 may featureresilient strengthening members (e.g., any of the nodules, fibers, orother strengthening member disclosed herein) to help strengthen the meshmaterial, prevent significant stretching of the mesh material, andsecure the mesh to the patient's tissue, as described herein.

Pelvic floor mesh 520, depicted in FIG. 18, has a trapezoidal centerregion 524 surrounded by two opposing sets 522 a and 522 b of three endregions each, where each end region is adapted to be implanted in apatient's tissue to hold the sling in the pelvic region of the patient.A perimeter 526 of the mesh 520 may have tangs, which are ends of fibersof the mesh material, that project from the perimeter 526 of the mesh520 and are adapted to penetrate patient tissue. The tangs may interactwith the patient's tissue by hooking into and adhering to the patient'stissue or stimulating scar tissue ingrowth. The mesh 520 may also oralternatively incorporate resilient strengthening members such as thosedescribed herein. For example, the sets 522 a and 522 b of end regionsmay have straight stiffening members 528 lying in a plane of the mesh520 and having perimeter protrusions 530 a and 530 b adapted topenetrate the patient's tissue to secure the sets 522 a and 522 b of endregions within the patient.

The mesh 540, depicted in FIG. 19, has four end regions 542 a, 542 b,542 c, and 542 d equally spaced around a circular center region 544,where each end region is adapted to be implanted in a patient's tissueto hold the sling in the pelvic region of the patient. A portion of, orsubstantially all of, the perimeter 546 may have tangs. The mesh 540 mayalso incorporate resilient strengthening members, as described above.For example, the end regions 542 a, 542 b, 542 c, and 542 d may havestiffening members 548 that are bent and disposed in a plane of the mesh540, and may also have perimeter protrusions 550 adapted to penetratethe patient's tissue to secure the end regions 542 a, 542 b, 542 c, and542 d within the patient.

Either mesh 520 or 540 can have a length suitable for allowing the meshto span the region of the patient's retropubic space between its twoobturator membranes. In certain embodiments, the mesh has a centerregion length 532 or 552, respectively, of between about 5 cm and about8 cm. Either mesh 520 or 540 can have an overall longitudinal length 534or 554, respectively, such as greater than about 7 cm, greater thanabout 9 cm, or from between about 10 cm to about 15 cm, and thus besized to span the patient's full obturator-to-obturator length and theanchor two or more of the end regions 542 a-542 d in respectiveobturator membranes.

Either mesh 520 or 540 can have an anterior-to-posterior width 536 or556, respectively, of between about 2.5 centimeters and about 8centimeters, which allows the mesh to extend under and providehammock-like support to posterior regions of the pelvic region,including, for example, the base of the bladder. In general, the meshcan have any desired anterior-to-posterior lengths to support variousanatomical regions of the pelvic floor. For example, either mesh 520 or540 can have an anterior-to-posterior length 536 or 556, respectively,of greater than about 3 cm, greater than about 5 cm, greater than about7 cm, or greater than about 10 cm to support the patient's urethra,bladderneck, and/or bladder.

FIG. 20 depicts an exemplary mesh 560 incorporating resilientstrengthening members. The mesh 560 has tangs 568 disposed alonglongitudinal edges 564 a and 564 b to help stimulate scar tissueingrowth and tissue adherence by end regions 562 a and 562 b. In certainembodiments, the tangs anchor the mesh in soft tissue. To help improvemesh resiliency and strength, the mesh 560 may have various resilientstrengthening members, such as strengthening fibers 570, which are showninterlaced with holes 566 of the mesh 560 and disposed in the endregions 562 a and 562 b. The mesh 560 may also have one or more of anyof the other strengthening members disclosed herein.

The exemplars described above in reference to FIGS. 2-20 are viablealternatives for mesh enhancement and serve merely as examples ofsuitable meshes and suitable resilient strengthening members. A specificmesh can optimize the number, types, orientations, and arrangement ofresilient strengthening members taking into consideration variables suchas mesh shape, implantation procedure, implantation location, organ tobe supported, and cost of materials and manufacturing. In certainembodiments the resilient strengthening members are disposed in endregions of the mesh, spaced away from a center region of the mesh. Thecenter region can underlie and support a urethra, bladderneck, orprolapsed pelvic organ within the patient, and may be left free ofprotrusions to avoid damaging or irritating the supported pelvicstructure. In certain embodiments, a resilient strengthening member isdisposed about mid-way between an end edge of the mesh and its center.In certain embodiments, the member is disposed about 10% of the way fromthe edge to the center. In other embodiments the member is disposedcloser to the center (e.g., between about mid-way to about 90% of theway to the center). Moreover, the concentration of strengthening membersmay vary according to the needs of the patient and depending on thetypes, sizes, and variety of strengthening members, the implantationlocations, and the implantation procedure. About 10% to about 90% of thesurface area of the mesh is coupled to a resilient strengthening member,and about 20% to about 40% of the mesh surface area is coupled to astrengthening member in certain implementations.

Exemplary methods and devices for delivering the exemplary meshesdisclosed herein to an anatomical location within the patient aredescribed below in reference to FIGS. 21-26B. Approaches that may beappropriate include transobturator, suprapubic, prepubic, andtransvaginal approaches. Other approaches may also be appropriate. Alloperative combinations between the disclosed meshes, resilientstrengthening members, delivery devices and these procedures arecontemplated. Any of the delivery devices described above may beemployed to create a passage through body tissue, for example, from theinferior pubic ramus through the obturator foramen to the vagina or thereverse according to the methodologies described herein.

As depicted in FIG. 21, in certain implementations an exemplary mesh 582is positioned within a sleeve 584 to aid in delivery of the mesh 582.The mesh 582 can incorporate various resilient strengthening members,such as stiffening members 592 disposed in the end regions 582 a and 582b of the mesh 582, similar to mesh 220 of FIG. 6. The mesh 582 may alsohave one or more of any of the other strengthening members disclosedherein. Each end of the sleeve 584 connects to a dilator tube 590 a or590 b which is connected to a respective end portion 584 a and 584 b, ofthe sleeve 584. The dilator tubes 590 a and/or 590 b may taper in adirection toward or away from the midpoint of the sling assembly 580depending on into which end of the guide tube a delivery device shaft isto be inserted. An exemplary delivery device is described below inreference to FIG. 22. The dilator tubes may be affixed to the slingassembly 580 ends by any suitable mechanism, including gluing, heatbonding, shrink tubing or the like.

In certain embodiments, the dilator tubes 590 a and 590 b are designedto slide onto the guide tube of a delivery device. In certainembodiments, the inner diameter of the dilator tubes 590 a and 590 b islarger than the diameter of the curved shaft or the diameter of at leastone section of the shaft, e.g., the distal end of the shaft. The dilatortubes 590 a and 590 b may be constructed so that the tip of the shaftentrains the dilator tubes 590 a and 590 b and carries them with it whenthe shaft is extended from the guide tube. In the depicted embodiment,the dilator tubes 590 a and 590 b are bonded to the sleeve 584, suchthat the dilator tubes 590 a and 590 b secure the respective ends 584 aand 584 b of the sleeve 584 of the sling assembly 580 to the tip of thedelivery device and facilitate expansion of tissue along a respectivepath during sling assembly placement. In other embodiments, the dilatortubes may include hooks or loops configured to engage in matingstructures, such as L-slots, formed onto the tip of the shaft. Asdescribed below, in other embodiments, the tubes 590 a and 590 b aresoft tissue anchors that are bonded to the sling and adapted to anchorthe sling to the patient's tissues and remain in place after placementof the sling. In certain embodiments, the tubes 590 a and 590 b are madeof a biodegradable material.

The sleeve 584 may be made, for example, from one or more absorbentmaterials, such as a sponge-like material, that can optionally bepre-soaked in a drug solution, for example, in an anesthetic,anti-inflammatory, coagulating, anticoagulating, or antibiotic solution.In another embodiment, the sleeve 584 may be made from a non-wettablematerial, such as polypropylene, polyethylene, polyester,polytetrafluoroethylene (available from DuPont Corporation, Wilmington,Del., under the trademark TEFLON™, TYVEK™, MYLAR™), or co-polymersthereof. The non-wettable materials can also be pretreated with atherapeutically effective drug coating. The sleeve 584 is preferablytransparent so that an operator will be able to see the mesh 582 insidethe sleeve 584.

FIG. 22 shows a delivery device 600 that can be used to deliver any ofthe exemplary meshes disclosed herein to an implantation location. Thedelivery device 600 includes a handle 602, a needle/shaft 608 extendingdistally from the handle 602, a pusher button 604 distal to the handle602, and a cannula 606 disposed about the shaft 608 and extendingdistally from the pusher button 604.

The shaft 608 is generally linear at its proximal end 608 a, and curvestowards its distal end 608 b. However, in other embodiments the shaft608 may be straight, may include any combination of curved sections andstraight sections, and/or may extend into one, two or more planes. Wheninserting the delivery device 600 through a vaginal incision and towardsan obturator membrane, a straight shaft may facilitate access for anoperator to more posterior regions of an obturator membrane, whereas ashaft with more curvature may facilitate access to more anterior regionsof an obturator membrane. In certain embodiments, the shaft may beshorter in length than the depicted shaft 608 which may provide anoperator with better control. In certain embodiments, the shaft 608 hasa diameter of between about 0.075 inches and about 0.2 inches, and incertain embodiments is about 0.107 inches. The shaft 608 includes a tip610. The tip 610 can be sharp and suited to incise and/or dissect humantissue, or blunt and suited for blunt dissection and/or dilation ofhuman tissue. In certain embodiments, the tip is blunt so as to avoiddamaging sensitive structures such as organs, nerves, and arteries, aswill be discussed below.

The pusher button 604 comprises polymeric materials and is mechanicallycoupled to the cannula 606. The cannula 606 is shorter in length thanthe shaft 608, and when the button 604 is in a retracted state, asdepicted in FIG. 22, the shaft 608 is exposed at its distal end. Incertain implementations, the exposed portion of the shaft 608 isslightly longer than about half the length of the mesh so that the meshremains external to the body during initial placement of the shaft 608.

The mesh can be coupled to any of the anchors described herein. Thecoupled anchors include respective axial through holes. The innerdiameter of the anchor is preferably sized and shaped to fit around andslide against the outer diameter of the shaft 608. The anchor slidesproximally along the shaft 608 and abuts the distal end of the pushercannula 606. The outer diameter of the anchor can be smaller, larger, orequal to the outer diameter of the pusher cannula 606. The mesh canfurther include a center mark in a center region of the mesh thatindicates the center, or “half-length,” of the mesh. In one usage ofdevice 600, the center mark of the mesh is placed directly underneaththe urethra. However, in other implementations, device 600 is used withlarger meshes that include marks which are placed under other anatomicalstructures, such as, for example, the base of the bladder.

The cannula 606 includes a pusher mark 612 that indicates where thecenter mark of the mesh will be positioned after the mesh has beenplaced using the delivery device 600. In one exemplary mode ofoperation, when an operator delivers the mesh using the delivery device600 with the pusher button 604 and the cannula 606 retracted, theoperator positions the pusher mark 612 underneath the urethra such thatwhen the operator advances the pusher, the center mark of the mesh liesabout or directly underneath the urethra. However, in embodimentswherein implants include marks indicating placement of the implant withrespect to another anatomical structure, such as the base of thebladder, the operator accordingly positions the pusher mark 612underneath that anatomical structure.

In operation, an operator couples an anchor of the mesh to the shaft608. The anchor slides proximally along the shaft 608 and abuts thedistal end of the pusher cannula 606. The operator inserts the shaft 608into the body of the patient and guides the tip 610 towards a targetregion while the button 604 is retracted. In certain implementations,the operator advances the tip past the target region. The operatoroptionally gauges his proximity to the target region by aligning thecenter mark with an anatomical landmark such as the urethra. Theoperator advances the button 604 distally, and thereby advances thedistal end of the cannula 606 towards the tip 610 of the shaft 608. Incertain implementations, the operator advances the anchor to a targetregion within the anatomy of the patient without pushing the anchor offof the shaft 608. Instead, after placement of the anchor, the operatorretracts the device 600 in a retrograde direction, which decouples theanchor from the shaft 608.

In addition to the cannula mark 612, the device 600 may include othermarks that guide the operator. In order to measure how far to advancethe button 604 and cannula 606, in certain embodiments the shaft 608includes increment/measurement markings 608 a etched into the shaft 608.The operator can use the measurement markings to gauge the distance fromthe tip 610 of the shaft to the distal end of the cannula 606. Themarkings 608 a can be disposed using other methods, such as disposing abiocompatible ink or stain on the shaft 608.

The exemplary meshes, anchors and delivery devices access target softtissue regions, such as the obturator membranes, via single vaginalincisions. Exemplary surgical techniques for implanting the meshesdisclosed herein will now be described. As illustrated herein, theprocedure can be applied with meshes that are configured to support theurethra or bladderneck for the treatment of UI; meshes that have longeranterior-to-posterior widths for supporting the bladder, uterus, and/orother organs located within the patient's pelvic region; and meshesincorporating resilient strengthening members such as those describedherein.

FIG. 23 illustrates an exemplary single vaginal incision procedure forusing delivery device 600 to deliver an exemplary mesh 620 designed tounderlie and support the urethra and/or bladderneck of the patient. Theexemplary mesh 620 is similar to mesh 260 of FIG. 8, and in particularincludes curved stiffening members 622 similar to members 268 of FIG. 8.The mesh 620 can be coupled to two soft tissue anchors 440 c and 440 d,one on each end of the mesh 620. The anchors 440 c and 440 d are similarto anchor 440 of FIG. 16A. The mesh 620 may also have one or more of anyof the other strengthening members disclosed herein.

In the exemplary technique, the patient is placed on an operating tablein a position to provide access to the pelvic region. The operator maysubject the patient to local anesthesia, regional anesthesia, and/orgeneral anesthesia or sedation according to his preference. Next, theoperator makes a transverse incision (not shown) in the anterior vaginalwall of the patient and dissects the incision bilaterally according tohis preference using, for example, surgical scissors. In certainimplementations, the operator dissects bilaterally to the inferior pubicramus on both sides of the patient. The operator then identifies a pathof delivery of the implant by palpating tissue of the pelvic region. Theoperator may palpate by inserting his finger through the vaginalincision and may identify anatomical structures such as the obturatorforamen.

Next, the operator accesses the patient's pelvic region via the singleincision to insert the implant into the patient's pelvic region andsecure the implant within the region so that at least a portion of theimplant is located posterior to the bladderneck. To accomplish this, theoperator first couples anchor 440 c to the tip 610 of the shaft 608,inserts the distal end of the shaft 608 into the body through theexternal vaginal opening 624 and then guides the distal end of the shaft608 through the vaginal incision towards an obturator membrane 626. Theoperator may palpate during delivery as preferred. The operator may alsouse the posterior portion of the patient's pubic bone as an anatomicallandmark to assist in guiding the needle. The operator optionallysecures the mesh 620 against the shaft 608 during delivery so that themesh 620 does not obstruct the operator's vision or the path of deliveryusing any suitable sterile securing means, such as a sterile elasticband or tie.

The operator then punctures the obturator membrane 626 with the tip 610but stops short of extending a portion of the tip 610 or shaft 608through the surface of the patient's skin in the groin. The location ofthe puncture within the obturator membrane 626 depends on the locationof the organ being supported. In certain implementations, the operatorgenerally delivers the mesh 620 along a path that avoids certain pelvicstructures, such as the internal pudendal artery, the pudendal canal,the perineal nerve, the labial nerve, and other vascular and nervestructures.

The operator may hear and/or feel a pop indicating that he has piercedthe obturator membrane 626. The operator gauges the length from thevaginal incision to the obturator 626 by using the markings orindications (not shown) on the shaft 608, by using the mark 612 (notshown in this figure) on the cannula 606, and/or by visually gauging thelength from the proximal edge of the anchor 440 c to the vaginalincision to assure that the length of the mesh 620 is suitable for thepatient. As mentioned above, in certain implementations, the mesh 620includes a visual marking that the operator places under a predeterminedanatomical landmark, such as the urethra or the bladder.

If needed, the operator further advances the shaft 608 to be near,contact, apply pressure to, poke (“tent-up”), or, in certain uses,pierce the epidermis (not shown) just beyond the obturator membrane 626,without penetrating entirely through the skin, until the shaft 608 is inan appropriate position to deliver the anchor 440 c. The operator mayexternally palpate the epidermis proximal to the obturator membrane tofeel the shaft 608 poke the epidermis and confirm its location. Incertain embodiments the operator stops extending the tip 610 when itreaches a position that is beneath the patient's stratum corneum, whilein other embodiments the operator stops the tip 610 from extending tothe epidermis. In certain embodiments the operator stops the tip 610 inthe subcutaneous tissue or beneath the subcutaneous and does not extendthe tip 610 to the dermal layer

In certain implementations, the incision is made in the vagina so as toallow the inserted shaft to be near, contact, apply pressure to, or pokethe skin at a position that is generally in line with the urethralmeatus. The operator anchors the anchor 440 c to the obturator membrane,and retracts the shaft 608, thereby decoupling the shaft 608 from theanchor 440 c, using methods discussed above.

The operator repeats the process on the contralateral side, deliveringanchors 440 d to the obturator membrane 628 through the same vaginalincision. The operator also inserts a center region of the mesh 620through the vaginal incision. In certain implementations the centerregion is inserted after the operator inserts the anchor 440 c on oneside of the patient but before inserting anchor 440 d on the other side.Once all of the anchors 440 c and 440 d are delivered through thevaginal incision in the anterior vaginal wall and extended to respectiveobturator membranes 626 and 628, the entire mesh 620 will have beendelivered through the vaginal opening 624 and through the vaginalincision, and thus lie in a region anterior to the vaginal canal andsupporting the urethra, bladder, and/or bladderneck.

Although cystoscopies are not required with the above-describedprocedure, the operator may perform a cystoscopy to check for bladderdamage after delivering any or all of the anchors.

Also during delivery, the operator optionally uses a pair of forceps oranother suitable medical instrument to space the mesh 620 from theurethra (not shown) during delivery of one or more of the anchors toprevent excessive tension or stress on the urethra. When completed, theoperator reviews the mesh 620 to confirm that it is properly placedunder the organ needing support, then sutures the vaginal incision.

For certain patients, the lateral length of the mesh 620 may be longerthan the obturator-to-obturator length of that patient. In these cases,the operator may leave equal lengths of the implant displaced onexternal sides of the obturator membranes 626 and 628. By way ofexample, if the mesh 620 has a lateral length of about 10 cm, then thepatient with obturator to obturator length of about 7 cm will have about1.5 cm of implant displaced on each side beyond the obturator membranes626 and 628. Alternately, the manufacturer can supply implants withvarious lateral lengths to suit various patients. The device 600 and asimilar delivery technique can be used to deliver meshes that areinstead sized and shaped for treating pelvic floor disorders.

The surgical methods described above are non-limiting examples. Otherswill be apparent upon review of this disclosure. In certain alternativeimplementations, devices used to insert the implants are set forth inFIGS. 24A-24C. In particular, FIGS. 24A-24C show another illustrativedelivery device 630 that is sized and shaped for transobtural placementof an implantable implant through the single vaginal incision, andemployable, without limitation, with any of the illustrative embodimentsdescribed herein. More particularly, the delivery device 630 includes ahandle 632 with first 632 a and second 632 b substantially straightsections located substantially in a first plane and angled relative toeach other, a transitional portion 638 extending out of a distal end 636of the handle 632 which interfits and extends axially out of the distalend 636 of the second straight handle section 632 b, and a halo-shapedcurved shaft 634 extending from a distal end of the transitional portion638. The curved shaft 634 includes a reduced diameter section 634 a at adistal end of the shaft 634 and an increased diameter section 634 b at aproximal end of the shaft 634. The increased diameter section 634 b andthe reduced diameter section 634 a adjoin to form a shoulder/ledge 634c. In use, an operator couples a soft tissue anchor to the device 630 byinterfitting the reduced diameter section 634 a of the shaft 634 througha through-aperture of the soft tissue anchor. The increased diametersection 634 should have a cross-section with a larger diameter than thediameter of the through-aperture, and thus the shoulder 634 c provides amechanical stop that prevents the anchor from sliding proximally alongthe shaft 634. In certain embodiments, the increased diameter section634 b and the reduced diameter section 634 a are manufactured from aunitary body. However, in other embodiments, the increased diametersection comprises a flexible sheath or covering that an operator slidesover the reduced diameter section 634 a and around the shaft 634.

In this embodiment, the first substantially straight section 632 a has alongitudinal axis 640 that is normal to the plane of the curved shaft634. However, the longitudinal axis 640 can form any suitable angle withrespect to the plane of the curved shaft (e.g., about 10, 20, 30, 45,60, 70 or 80 degrees). By way of example, a device similar to device 630of FIGS. 24A-24C can have alternative flat handles, tapered tips atdistal ends of the curved shafts, and longitudinal axes that form anglesof about 60 degrees with respect to the planes of the curved shafts.

Described now with respect to FIG. 25 is another illustrative method fordelivering a mesh to an anatomical site in the body of a patient. Themesh can incorporate any of the resilient strengthening membersdisclosed herein, such as straight stiffening members 688, which areshown arrayed in overlapping X structures similar to mesh 180 of FIG.4B. The illustrative method includes an outside-in trans-obturatorapproach.

A first incision 668 b is made on the inside of the patient's thigh, forexample, about 1 cm outside the external margin of the labia majora. Theoperator inserts the shaft 662 of the delivery device 664, tip first,into the first incision 668 b and continues to penetrate a firstobturator foramen 656 b. With a rotating wrist motion, the shaft 662 isguided along the posterior ischiopubic ramus to a vaginal incision 660on the vaginal wall 670. After a distal portion 658 of the shaft 662emerges out of the vaginal wall 670, the operator associates a distalend of the shaft 662 with a first end of a mesh assembly 680.

According to one illustrative embodiment, the distal end of the shaft662 includes an L-slot onto which an association loop located at thefirst end of the mesh assembly may be hooked. More particularly, a firstassociation loop is slid over the distal end 658 of the shaft 662 of thedelivery device and radially into a first channel. The association loopis then moved distally away from the delivery device within a secondchannel to hook one end of the mesh assembly onto the delivery device.The delivery device is then withdrawn from the ishiopubic incision,drawing the end of the sling assembly through the passage created by theshaft 662. The orientation of the L-slot with respect to the ishiopubicapproach ensures that the association loop is tensioned toward theclosed, distal end of the L-slot as the delivery device is withdrawn.Subsequent to withdrawal, the association loop and the distal end 658 ofthe shaft 662 are oriented perpendicularly to each other, and then theassociation loop is unhooked from the delivery device.

The process can then be repeated with the same or a second deliverydevice on the contralateral side of the body with a second associationloop, such as the association loop of the mesh assembly 680. Optionally,a single cystoscopy may be performed with two delivery devices in place,prior to withdrawal of the delivery devices to verify integrity of thebladder. Cystoscopy could also be performed, as desired, after eachplacement of a delivery device on a side of the body.

In an alternative approach, a guide, such as the dilator tubes 590 a and590 b of FIG. 21, extends from each sling assembly end 654 a and 654 b.The dilator tube can be slid over the distal end 658 of the shaft 662.Then, the operator withdraws the shaft 662 of the delivery device backout of the obturator foramen 656 b, bringing the sleeve end of the slingassembly 680 out of the first thigh incision 668 b.

Once again, the process can then be repeated with the same or a seconddelivery device on the contralateral side of the body with a seconddilator tube. Optionally, a single cystoscopy may be performed with twodelivery devices in place, prior to withdrawal of the delivery devicesto verify integrity of the bladder. Cystoscopy may also be performed, asdesired, after each placement of a delivery device on a side of thebody. Once desired placement of the sling assembly is achieved, thetabbed spacer 686 is cut. Then, by pulling on the guides or dilatortubes, as the case may be, the medical operator can slide the sleeve 682a off the sling 684 and remove it from the body. The delivery device(s)and the plastic sleeve 682 a, including the guides or the dilator tubes,as the case may be, may then be discarded. In some embodiments the slingends are anchored or otherwise affixed to muscle, tissue, or bone withinthe pelvic region of the body using stiffening members 688.

FIGS. 26A and 26B depict an illustrative inside-out transobtural methodfor delivering an exemplary mesh to an implantation location. FIG. 26Adepicts a mesh 700 directly coupled to the delivery device 630 that wasshown in FIGS. 24A-24C. The mesh 700 includes tanged portions 702 a and702 b at respective ends of the implant 700, and a non-tanged portion702 c between the tanged portions 702 a and 702 b. The mesh 700 can alsoincorporate resilient strengthening members, such as curved stiffeningmembers 708, arrayed similarly to curved stiffening members 286 of FIGS.9A and 9B, and strengthening bars 710, arrayed similarly tostrengthening bars 430 of FIGS. 15A and 15B. The curved stiffeningmembers 708 each have protrusions 708 a and 708 b formed along both top100 a on bottom (not shown) surfaces of the mesh 700 within regions ofthe tanged portions 702 a and 702 b. This arrangement advantageously hasprotrusions in end regions of the mesh 700 along both longitudinalsurfaces and both longitudinal edges to help secure the end regionswithin the patient's tissue, which may obviate the need for an anchor.The mesh 700 may also have one or more of any of the other strengtheningmembers disclosed herein.

In use, the operator couples the implant 700 directly to the deliverydevice 630 by sliding the reduced diameter portion 634 a through one ofthe holes 704 of the mesh 700. In order for the reduced diameter portion634 a to fit through one of the interstices, in certain embodiments thereduced diameter portion 634 a has a diameter of less than about 1 mm.The operator then guides the distal end of the delivery device 630 tothe obturator membrane 706 b. However, instead of piercing a soft tissueanchor through the obturator membrane, the operator drives the reduceddiameter portion 634 a of the device 630 with at least part of thetanged portion 702 b having stiffening members 708 through the obturatormembrane 706 b. The delivery device 630 is then withdrawn through thevaginal incision leaving the tanged portion 702 b implanted in orthrough the obturator membrane 706 b. The operator then repeats thisprocess to anchor the contra-lateral tanged portion 702 a to thecontra-lateral obturator membrane 706 a.

The tanged mesh 700 is sized and shaped to treat urinary incontinence bysupporting the patient's urethra and/or bladderneck. Tanged meshesincorporating strengthening members can also be used for treating otherpelvic floor disorders. FIG. 26B shows an oblique view of the pelvicregion 720 of a patient with a mesh 722 similar to the implant 520 ofFIG. 18, but having tanged straps 722 a-f incorporating retentionnodules 728 similar to retention nodules 428 of FIG. 15. Similarly tothe strengthening members 708 of FIG. 26A, the nodules 728 protrudealong longitudinal surfaces of the tanged straps 722 a-f. Thisarrangement advantageously has protrusions in end regions of the mesh720 along both longitudinal surfaces and both longitudinal edges to helpsecure the end regions within the patient's tissue, which may obviatethe need for anchors. The mesh 700 may also have one or more of any ofthe other strengthening members disclosed herein. To deliver the mesh722, the operator uses a similar method as that described in connectionwith FIG. 26A to deliver each of the tanged ends 722 a-c to a firstobturator membrane 724 and to then deliver each of the tanged straps 722d-f to a contra-lateral obturator membrane 726.

After placing a surgical implant, the operator may tension the implantto provide the proper support to anatomical structures of the pelvicregion using methods described above.

In addition to the obturator membranes, in certain alternativeimplementations an operator may elect to anchor the implant to otheranatomical structures. These structures include posterior or lateraltissues or muscles, such as the sacrospinous ligament and the levatorani muscle. The sacrospinous ligament is a thin and triangular tissuethat is attached by its apex to the spine of the patient's ischium, andmedially, by its broad base, to the lateral margins of the sacrum andcoccyx in front of the sacrotuberous ligament. The sacrospinous ligamentis a convenient location to anchor mesh straps in the posterior regionsof the pelvic floor in order to provide posterior support. The levatorani muscle is a broad, thin muscle situated generally on the side of thepelvis that is attached to the inner surface of the lesser pelvis. It isa convenient location to anchor mesh straps in order to provide lateraland/or posterior support and tension for a surgical implant.

The resilient strengthening members described herein, including theexemplary stiffening members, fibers, retention nodules, strengtheningbars, and anchors, are configured from synthetic materials,non-synthetic materials, or both. In certain embodiments, the resilientstrengthening members are biodegradable, either in whole or in part, andsuch embodiments may employ any of the materials referenced herein. Theresilient strengthening members may be made from biocompatible metals,composites, plastics or other polymeric materials. Examples of suitablemetals include, but are not limited to, stainless steel, titanium, andalloys such as nickel-titanium of nitinol. Suitable polymers, which canbe used as a coating on a metal, include but are not limited to,plastics such as polytetrafluoroethylene. Moreover, the resilientstrengthening members may be prepared to include a protective coating ortreatment, and may also be configured to contain an agent for releaseinto the patient's tissues. Any resilient strengthening membersdescribed herein may incorporate any of the materials described herein.

The resilient strengthening members may be manufactured by any suitableapproach, including extrusion, injection molding, or spinning. Theresilient strengthening members may be also be formed by disposing ontothe mesh (e.g., mesh 100 depicted in FIG. 1) a molten material whichlater solidifies to form the components. The disposed molten materialmay or may not penetrate an exterior surface of the mesh 100. Theresilient strengthening members may also be attached to the mesh 100 byany other suitable method. For example, the resilient strengtheningmembers may be glued, heat-bonded, fused, woven, or tied to the mesh100.

The mesh described herein may be fabricated from any suitablematerial(s), preferably biocompatible materials, and may benon-biodegradable or biodegradable. The non-biodegradable portions ofthe mesh may be fabricated from any of a plurality of biocompatiblematerials, such as nylon, silicone, polyethylene, polyester,polyethylene, polyurethane, polypropylene, polyvinyl polymers,fluoropolymers, copolymers thereof, combinations thereof, or othersuitable synthetic material(s). The biodegradable portions of the mesh100 may be derived from mammalian tissue, synthetic materials, or acombination of mammalian tissue and synthetic material. According tosome configurations, the biodegradable portions of the mesh 100 areformed from synthetic polymers, such as polylactic acid, polyglycolicacid, or natural polymers, such as collagen, cellulose, polypeptides,polysaccharides, or copolymers thereof. According to someconfigurations, bioactive compounds may be added to the biodegradablepolymers to enhance acute inflammation and encourage scar tissueformation. Examples of these inflammation promoters are fibrinogen andfibrin. The mesh 100 may incorporate or be coated with one or moreagents to provide a therapeutic effect, for example, to reducediscomfort, to reduce the chance of infection, increasebiocompatibility, and/or to promote tissue ingrowth. More examples ofmesh materials are described below.

Exemplary mesh materials include, for example, synthetic materials,natural materials (e.g., biological) or a combination thereof. Thenon-degradable portion of the mesh may be fabricated from any of anumber of non-degradable biocompatible materials, such as nylon,silicone, polyethylene, polyester, polyethylene, polyurethane,polypropylene, fluoropolymers, copolymers thereof, combinations thereof,or other suitable synthetic material(s). The biodegradable component ofthe mesh may be any suitable biodegradable material. The biodegradablematerial may be, for example, a biodegradable synthetic material. Theterm “biodegradable,” is used synonymously with “bioabsorbable” and with“degradable” herein, and refers to the property of a material thatdissolves in the body or is absorbed into the body. A mesh material maybe fabricated from one or more yarns, which yarns may be made from oneor more materials.

Suitable bioabsorbable synthetic materials include, without limitation,polylactic acid (PLA), polyglycolic acid (PGA), poly-L-lactic acid(PLLA), human dermis and decellularized animal tissue. Human tissues maybe derived, for example, from human cadaveric or engineered humantissue. Animal tissues may be derived, for example, from porcine, ovine,bovine, and equine tissue sources. The material may be anomnidirectional material, a material that has equivalent tensilestrength from any direction, such as pericardium or dermis.Alternatively, the material may be an oriented material, a material thathas a single direction where the tensile strength of the material is thehighest. Oriented materials may include rectus fascia and/or facia lata.

Exemplary biodegradable polymers, which may be used to form a mesh, inaddition to those listed above, include, without limitation, polylacticacid, polyglycolic acid and copolymers and mixtures thereof, such aspoly(L-lactide) (PLLA), poly(D,L-lactide) (PLA), polyglycolic acid[polyglycolide (PGA)], poly(L-lactide-co-D,L-lactide) (PLLA/PLA),poly(L-lactide-co-glycolide) (PLLA/PGA), poly(D,L-lactide-co-glycolide)(PLA/PGA), poly(glycolide-co-trimethylene carbonate) (PGA/PTMC),poly(D,L-lactide-co-caprolactone) (PLA/PCL), andpoly(glycolide-co-caprolactone) (PGA/PCL); polyethylene oxide (PEO);polydioxanone (PDS); polypropylene fumarate; polydepsipeptides,poly(ethyl glutamate-co-glutamic acid),poly(tert-butyloxy-carbonylmethyl glutamate); polycaprolactone (PCL),poly(hydroxy butyrate), polycaprolactone co-butylacrylate,polyhydroxybutyrate (PHBT) and copolymers of polyhydroxybutyrate;polyphosphazenes, poly(phosphate ester); maleic anhydride copolymers,polyiminocarbonates, poly[(97.5% dimethyl-trimethylenecarbonate)-co-(2.5% trimethylene carbonate)], cyanoacrylate,hydroxypropylmethylcellulose; polysaccharides, such as hyaluronic acid,chitosan and regenerate cellulose; poly(amino acid) and proteins, suchas gelatin and collagen; and mixtures and copolymers thereof.

In various implementations of the invention, the mesh, either as a wholeor on a fiber by fiber basis, may include an agent for release into thepatient's tissues. One illustrative agent is a tissue growth factor thatpromotes, when applied to the patient's tissues in a pharmaceuticallyacceptable amount, well-organized collagenous tissue growth, such asscar tissue growth, preferably, in large quantities. According to onefeature, the agent may or may not block or delay the dissolvability ofthe biodegradable materials. This may be controlled by selectingdiffering methods for loading the agent onto the sling. The tissuegrowth factor may include natural and/or recombinant proteins forstimulating a tissue response so that collagenous tissue such as scartissue growth is enhanced.

Exemplary growth factors that may be used include, but are not limitedto, platelet-derived growth factor (PDGF), fibroblast growth factor(FGF), transforming growth factor-beta (TGF-beta), vascular endotheliumgrowth factor (VEGF), Activin/TGF and sex steroid, bone marrow growthfactor, growth hormone, Insulin-like growth factor 1, and combinationsthereof. The agent may also include a hormone, including but not limitedto estrogen, steroid hormones, and other hormones to promote growth ofappropriate collagenous tissue such as scar tissue. The agent may alsoinclude stem cells or other suitable cells derived from the hostpatient. These cells may be fibroblast, myoblast, or other progenitorcells to mature into appropriate tissues.

In various illustrative embodiments, the agent may include one or moretherapeutic agents. The therapeutic agents may be, for example,anti-inflammatory agents, including steroidal and non-steroidalanti-inflammatory agents, analgesic agents, including narcotic andnon-narcotic analgesics, local anesthetic agents, antispasmodic agents,growth factors, gene-based therapeutic agents, and combinations thereof.

Exemplary steroidal anti-inflammatory therapeutic agents(glucocorticoids) include, but are not limited to,21-acetoxyprefnenolone, aalclometasone, algestone, amicinonide,beclomethasone, betamethasone, budesonide, chloroprednisone, clobetasol,clobetasone, clocortolone, cloprednol, corticosterone, cortisone,cortivazol, deflazacort, desonide, desoximetasone, dexamethasone,diflorasone, diflucortolone, difluprednate, enoxolone, fluazacort,flucloronide, flumehtasone, flunisolide, fluocinolone acetonide,fluocinonide, fluocortin butyl, fluocortolone, fluorometholone,fluperolone acetate, fluprednidene acetate, fluprednisolone,flurandrenolide, fluticasone propionate, formocortal, halcinonide,halobetasol priopionate, halometasone, halopredone acetate,hydrocortamate, hydrocortisone, loteprednol etabonate, mazipredone,medrysone, meprednisone, methyolprednisolone, mometasone furoate,paramethasone, prednicarbate, prednisolone, prednisolone25-diethylaminoacetate, prednisone sodium phosphate, prednisone,prednival, prednylidene, rimexolone, tixocortal, triamcinolone,triamcinolone acetonide, triamcinolone benetonide, triamcinolonehexacetonide, and pharmaceutically acceptable salts thereof.

Exemplary non-steroidal anti-inflammatory therapeutic agents include,but are not limited to, aminoarylcarboxylic acid derivatives such asenfenamic acid, etofenamate, flufenamic acid, isonixin, meclofenamicacid, mefanamic acid, niflumic acid, talniflumate, terofenamate andtolfenamic acid; arylacetic acid derivatives such as acemetacin,alclofenac, amfenac, bufexamac, cinmetacin, clopirac, diclofenac sodium,etodolac, felbinac, fenclofenac, fenclorac, fenclozic acid, fentiazac,glucametacin, ibufenac, indomethacin, isofezolac, isoxepac, lonazolac,metiazinic acid, oxametacine, proglumetacin, sulindac, tiaramide,tolmetin and zomepirac; arylbutyric acid derivatives such as bumadizon,butibufen, fenbufen and xenbucin; arylcarboxylic acids such as clidanac,ketorolac and tinoridine; arylpropionic acid derivatives such asalminoprofen, benoxaprofen, bucloxic acid; carprofen, fenoprofen,flunoxaprofen, flurbiprofen, ibuprofen, ibuproxam, indoprofen,ketoprofen, loxoprofen, miroprofen, naproxen, oxaprozin, piketoprofen,pirprofen, pranoprofen, protizinic acid, suprofen and tiaprofenic acid;pyrazoles such as difenamizole and epirizole; pyrazolones such asapazone, benzpiperylon, feprazone, mofebutazone, morazone,oxyphenbutazone, phenybutazone, pipebuzone, propyphenazone,ramifenazone, suxibuzone and thiazolinobutazone; salicylic acidderivatives such as acetaminosalol, aspirin, benorylate, bromosaligenin,calcium acetylsalicylate, diflunisal, etersalate, fendosal, gentisicacid, glycol salicylate, imidazole salicylate, lysine acetylsalicylate,mesalamine, morpholine salicylate, 1-naphthyl salicylate, olsalazine,parsalmide, phenyl acetylsalicylate, phenyl salicylate, salacetamide,salicylamine o-acetic acid, salicylsulfuric acid, salsalate andsulfasalazine; thiazinecarboxamides such as droxicam, isoxicam,piroxicam and tenoxicam; others such as *-acetamidocaproic acid,s-adenosylmethionine, 3-amino-4-hydroxybutyric acid, amixetrine,bendazac, benzydamine, bucolome, difenpiramide, ditazol, emorfazone,guaiazulene, nabumetone, nimesulide, orgotein, oxaceprol, paranyline,perisoxal, pifoxime, proquazone, proxazole and tenidap; andpharmaceutically acceptable salts thereof.

Exemplary narcotic analgesic therapeutic agents include, but are notlimited to, alfentanil, allylprodine, alphaprodine, anileridine,benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene,codeine, codeine methyl bromide, codeine phosphate, codeine sulfate,desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine,dihydrocodeinone enol acetate, dihydromorphine, dimenoxadol,dimepheptanol, dimethylthiambutene, dioxaphetyl butyrate, dipipanone,eptazocine, ethoheptazine, ethylmethylthiambutene, ethylmorphine,etonitazene, fentanyl, hydrocodone, hydromorphone, hydroxypethidine,isomethadone, ketobemidone, levorphanol, lofentanil, meperidine,meptazinol, metazocine, methadone hydrochloride, metopon, morphine,myrophine, nalbuphine, narceine, nicomorphine, norlevorphanol,normethadone, normorphine, norpipanone, opium, oxycodone, oxymorphone,papavereturn, pentazocine, phenadoxone, phenazocine, pheoperidine,piminodine, piritramide, proheptazine, promedol, properidine, propiram,propoxyphene, rumifentanil, sufentanil, tilidine, and pharmaceuticallyacceptable salts thereof.

Exemplary non-narcotic analgesic agents that may be combined with theslings of the invention include, but are not limited to, aceclofenac,acetaminophen, acetaminosalol, acetanilide, acetylsalicylsalicylic acid,alclofenac, alminoprofen, aloxiprin, aluminum bis(acetylsalicylate),aminochlorthenoxazin, 2-amino-4-picoline, aminopropylon, aminopyrine,ammonium salicylate, amtolmetin guacil, antipyrine, antipyrinesalicylate, antrafenine, apazone, aspirin, benorylate, benoxaprofen,benzpiperylon, benzydamine, bermoprofen, brofenac, p-bromoacetanilide,5-bromosalicylic acid acetate, bucetin, bufexamac, bumadizon, butacetin,calcium acetylsalicylate, carbamazepine, carbiphene, carsalam,chloralantipyrine, chlorthenoxazin(e), choline salicylate, cinchophen,ciramadol, clometacin, cropropamide, crotethamide, dexoxadrol,difenamizole, diflunisal, dihydroxyaluminum acetylsalicylate,dipyrocetyl, dipyrone, emorfazone, enfenamic acid, epirizole,etersalate, ethenzamide, ethoxazene, etodolac, felbinac, fenoprofen,floctafenine, flufenamic acid, fluoresone, flupirtine, fluproquazone,flurbiprofen, fosfosal, gentisic acid, glafenine, ibufenac, imidazolesalicylate, indomethacin, indoprofen, isofezolac, isoladol, isonixin,ketoprofen, ketorolac, p-lactophenetide, lefetamine, loxoprofen, lysineacetylsalicylate, magnesium acetylsalicylate, methotrimeprazine,metofoline, miroprofen, morazone, morpholine salicylate, naproxen,nefopam, nifenazone, 5′ nitro-2′ propoxyacetanilide, parsalmide,perisoxal, phenacetin, phenazopyridine hydrochloride, phenocoll,phenopyrazone, phenyl acetylsalicylate, phenyl salicylate, phenyramidol,pipebuzone, piperylone, prodilidine, propacetamol, propyphenazone,proxazole, quinine salicylate, ramifenazone, rimazolium metilsulfate,salacetamide, salicin, salicylamide, salicylamide o-acetic acid,salicylsulfinuric acid, salsalte, salverine, simetride, sodiumsalicylate, sulfamipyrine, suprofen, talniflumate, tenoxicam,terofenamate, tetradrine, tinoridine, tolfenamic acid, tolpronine,tramadol, viminol, xenbucin, zomepirac, and pharmaceutically acceptablesalts thereof.

Exemplary local anesthetic therapeutic agents include, but are notlimited to, ambucaine, amolanone, amylocalne hydrochloride, benoxinate,benzocaine, betoxycaine, biphenamine, bupivacaine, butacaine, butaben,butanilicaine, butethamine, butoxycaine, carticaine, chloroprocainehydrochloride, cocaethylene, cocaine, cyclomethycaine, dibucainehydrochloride, dimethisoquin, dimethocaine, diperadon hydrochloride,dyclonine, ecgonidine, ecgonine, ethyl chloride, beta-eucaine, euprocin,fenalcomine, fomocaine, hexylcaine hydrochloride, hydroxytetracaine,isobutyl p-aminobenzoate, leucinocaine mesylate, levoxadrol, lidocaine,mepivacaine, meprylcaine, metabutoxycaine, methyl chloride, myrtecaine,naepaine, octacaine, orthocaine, oxethazaine, parethoxycaine, phenacainehydrochloride, phenol, piperocaine, piridocaine, polidocanol, pramoxine,prilocalne, procaine, propanocaine, proparacaine, propipocaine,propoxycaine hydrochloride, pseudococaine, pyrrocaine, ropavacaine,salicyl alcohol, tetracaine hydrochloride, tolycaine, trimecaine,zolamine, and pharmaceutically acceptable salts thereof.

Exemplary antispasmodic therapeutic agents include, but are not limitedto, alibendol, ambucetamide, aminopromazine, apoatropine, bevoniummethyl sulfate, bietamiverine, butaverine, butropium bromide,n-butylscopolammonium bromide, caroverine, cimetropium bromide,cinnamedrine, clebopride, coniine hydrobromide, coniine hydrochloride,cyclonium iodide, difemerine, diisopromine, dioxaphetyl butyrate,diponium bromide, drofenine, emepronium bromide, ethaverine, feclemine,fenalamide, fenoverine, fenpiprane, fenpiverinium bromide, fentoniumbromide, flavoxate, flopropione, gluconic acid, guaiactamine,hydramitrazine, hymecromone, leiopyrrole, mebeverine, moxaverine,nafiverine, octamylamine, octaverine, oxybutynin chloride,pentapiperide, phenamacide hydrochloride, phloroglucinol, pinaveriumbromide, piperilate, pipoxolan hydrochloride, pramiverin, prifiniumbromide, properidine, propivane, propyromazine, prozapine, racefemine,rociverine, spasmolytol, stilonium iodide, sultroponium, tiemoniumiodide, tiquizium bromide, tiropramide, trepibutone, tricromyl,trifolium, trimebutine, n,n-ltrimethyl-3,3-diphenyl-propylamine,tropenzile, trospium chloride, xenytropium bromide, and pharmaceuticallyacceptable salts thereof.

In another aspect, the invention also includes methods of implanting asurgical mesh, such as the meshes described herein, within a patient forthe treatment of urinary incontinence, pelvic floor prolapse, or both.In certain implementations, the meshes disclosed herein are adapted forimplantation through transobtural, transabdominal, supra pubic, prepubicor other techniques. In certain implementations, the meshes may beinserted into the patient through a single vaginal incision surgicaltechnique, such as the techniques disclosed in U.S. application Ser. No.11/400,111, and entitled “Systems, Devices and Methods for TreatingPelvic Floor Disorders,” filed Apr. 6, 2006, the contents of which arehereby incorporated by reference in their entirety.

According to another feature, the implants of the invention may includeany suitable end portions, such as tissue dilators, anchors, andassociation mechanisms for associating the sling with the deliverydevices of the invention. They may also include other slings, slingassemblies, sling delivery approaches, sling assembly-to-delivery deviceassociation mechanisms, and sling anchoring mechanisms. These and otherfeatures with which the delivery devices, implants, methods, and kits ofthe invention may be employed are disclosed in U.S. Pat. No. 6,042,534,entitled “Stabilization sling for use in minimally invasive pelvicsurgery,” U.S. Pat. No. 6,755,781, entitled “Medical slings,” U.S. Pat.No. 6,666,817, entitled “Expandable surgical implants and methods ofusing them,” U.S. Pat. No. 6,042,592, entitled “Thin soft tissuesurgical support mesh,” U.S. Pat. No. 6,375,662, entitled “Thin softtissue surgical support mesh,” U.S. Pat. No. 6,669,706, entitled “Thinsoft tissue surgical support mesh,” U.S. Pat. No. 6,752,814, entitled“Devices for minimally invasive pelvic surgery,” U.S. Ser. No.10/918,123, entitled “Surgical Slings,” U.S. patent application Ser. No.10/641,376, entitled “Spacer for sling delivery system,” U.S. patentapplication Ser. No. 10/641,192, entitled “Medical slings,” U.S. Ser.No. 10/641,170, entitled “Medical slings,” U.S. Ser. No. 10/640,838,entitled “Medical implant,” U.S. patent application Ser. No. 10/460,112,entitled “Medical slings,” U.S. patent application Ser. No. 10/631,364,entitled “Bioabsorbable casing for surgical sling assembly,” U.S. Ser.No. 10/092,872, entitled “Medical slings,” U.S. patent application Ser.No. 10/939,191, entitled “Devices for minimally invasive pelvicsurgery,” U.S. patent application Ser. No. 10/774,842, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/774,826, entitled “Devices for minimally invasive pelvic surgery,”U.S. Ser. No. 10/015,114, entitled “Devices for minimally invasivepelvic surgery,” U.S. patent application Ser. No. 10/973,010, entitled“Systems and methods for sling delivery and placement,” U.S. patentapplication Ser. No. 10/957,926, entitled “Systems and methods fordelivering a medical implant to an anatomical location in a patient,”U.S. patent application Ser. No. 10/939,191, entitled “Devices forminimally invasive pelvic surgery,” U.S. patent application Ser. No.10/918,123, entitled “Surgical slings,” U.S. patent application Ser. No.10/832,653, entitled “Systems and methods for sling delivery andplacement,” U.S. patent application Ser. No. 10/642,397, entitled“Systems, methods and devices relating to delivery of medical implants,”U.S. patent application Ser. No. 10/642,395, entitled “Systems, methodsand devices relating to delivery of medical implants,” U.S. patentapplication Ser. No. 10/642,365, entitled “Systems, methods and devicesrelating to delivery of medical implants,” U.S. patent application Ser.No. 10/641,487, entitled “Systems, methods and devices relating todelivery of medical implants,” U.S. patent application Ser. No.10/094,352, entitled “System for implanting an implant and methodthereof,” U.S. patent application Ser. No. 10/093,498, entitled “Systemfor implanting an implant and method thereof,” U.S. patent applicationSer. No. 10/093,450, entitled “System for implanting an implant andmethod thereof,” U.S. patent application Ser. No. 10/093,424, entitled“System for implanting an implant and method thereof,” U.S. patentapplication Ser. No. 10/093,398, entitled “System for implanting animplant and method thereof,” and U.S. patent application Ser. No.10/093,371, entitled “System for implanting an implant and methodthereof,” U.S. Pat. No. 6,197,036, entitled “Pelvic FloorReconstruction,” U.S. Pat. No. 6,691,711, entitled “Method of Correctionof Urinary and Gynecological Pathologies Including Treatment ofIncontinence,” U.S. Pat. No. 6,884,128, entitled “Implantable Articleand Method,” U.S. Pat. No. 6,911,003, entitled “Transobturator SurgicalArticles and Methods,” U.S. patent application Ser. No. 10/840,646,entitled “Method and Apparatus for Cystocele Repair,” U.S. applicationSer. No. 10/834,943, entitled “Method and Apparatus for Treating PelvicOrgan Prolapse,” U.S. patent application Ser. No. 10/804,718, entitled“Prolapse Repair,” U.S. patent application Ser. No. 10/957,926, entitled“Systems and Methods for Delivering a Medical Implant to an AnatomicalLocation in a Patient,” U.S. patent application Ser. No. 11/115,655,entitled “Surgical Implants and Related Methods,” and U.S. patentapplication Ser. No. 11/399,913, entitled “Systems, Methods, and Devicesfor Sub-urethral Support.” The entire contents of all cited referencesare incorporated herein by reference in their entirety.

The foregoing embodiments are merely examples of various configurationsof the resilient strengthening members and meshes described anddisclosed herein and are not to be understood as limiting in any way.Additional configurations can be readily deduced from the foregoing,including combinations thereof, and such configurations and combinationsare included within the scope of the invention. Variations,modifications, and other implementations of what is described may beemployed without departing from the spirit and the scope of theinvention. More specifically, any of the method, system and devicefeatures described above or incorporated by reference may be combinedwith any other suitable method, system, or device features disclosedherein or incorporated by reference, and is within the scope of thecontemplated inventions. The specifications and other disclosures in thepatents, patent applications, and other references cited herein arehereby incorporated by reference in their entirety.

1. An implant for use in treating a pelvic floor condition in a patient,comprising: a mesh having at least one longitudinal edge and at leastone longitudinal surface and being sized and shaped to support one ormore of a patient's urethra, bladderneck, and pelvic organ; and aresilient strengthening member disposed within or on the mesh andprotruding beyond one or more of a longitudinal edge and a longitudinalsurface.
 2. The implant of claim 1, wherein the resilient strengtheningmember protrudes beyond a first longitudinal edge of the mesh and asecond longitudinal edge of the mesh.
 3. The implant of claim 1, whereinthe resilient strengthening member is attached to the mesh at aplurality of points.
 4. The implant of claim 1, wherein the resilientstrengthening member is a rigid member having a portion adapted topenetrate a tissue of a patient.
 5. The implant of claim 4, wherein therigid member is oblong.
 6. The implant of claim 5, wherein the rigidmember is disposed obliquely with respect to the longitudinal edge. 7.The implant of claim 5, wherein the rigid member is disposedsubstantially perpendicular to the longitudinal edge.
 8. The implant ofclaim 5, wherein the rigid member is disposed substantially parallel tothe longitudinal edge.
 9. The implant of claim 1, wherein the resilientstrengthening member includes a rigid member deposited on a surface ofthe mesh.
 10. The implant of claim 1, wherein the mesh is configured inan irregular shape for pelvic organ support.
 11. The implant of claim10, wherein the mesh includes one or more securement straps, and atleast one of the one or more securement straps includes a resilientstrengthening member disposed in an end region of the securement strap.12. The implant of claim 1, wherein an end region of the mesh isconfigured in an irregular shape for securing to a location within thepatient.
 13. The implant of claim 1, wherein the resilient strengtheningmember is disposed in an end region of the mesh.
 14. The implant ofclaim 13, wherein the resilient strengthening member is disposed inwardfrom an end edge of the mesh.
 15. The implant of claim 13, wherein theresilient strengthening member is disposed at least about 25% of a wayfrom an end of the mesh to a center of the mesh.
 16. The implant ofclaim 13, wherein the resilient strengthening member is spaced away froma center region of the mesh, said center region being adapted to beadjacent to one or more of the patient's urethra, bladderneck, andpelvic organ.
 17. The implant of claim 1, wherein the resilientstrengthening member has plastic or metal.
 18. The implant of claim 1,further comprising an anchor disposed at an end of the mesh for securingthe implant to soft tissue within a patient.
 19. The implant of claim 1,wherein the mesh includes an end region having tangs that project from alongitudinal edge.
 20. The implant of claim 1, further comprising aplurality of resilient strengthening members.
 21. The implant of claim20, further comprising a first plurality of resilient strengtheningmembers disposed in a first end region of the mesh and a secondplurality of resilient strengthening members disposed in a second endregion of the mesh.
 22. The implant of claim 20, wherein two or moreresilient strengthening members directly connect.
 23. The implant ofclaim 22, wherein the two or more resilient strengthening members areaffixed to each other.
 24. The implant of claim 1, wherein at least oneresilient strengthening member couples to a plurality of other resilientstrengthening members.
 25. A method for implanting a surgical implant inthe pelvic floor region of a patient comprising: creating an incision inthe vaginal wall of the patient, coupling an implant to a deliverydevice, wherein the implant is a mesh implant having a longitudinaledge, a longitudinal surface, and a resilient strengthening memberdisposed within or on the mesh implant and protruding beyond one or moreof the longitudinal edge and the longitudinal surface, and inserting thedelivery device through the vaginal incision via the external vaginalopening of the patient to extend a portion of the implant within thepatient's pelvic region.
 26. The method of claim 25, further comprisingguiding the device to a location beneath the patient's epidermis tosecure the implant in the patient's soft tissue.